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作 者:孙超[1] 刘景波[1] 张昊天[1] 袁哲[1] 王跃[1] 尹燕杰[1] 刚宏林[1]
机构地区:[1]哈尔滨市食品药品检验检测中心,哈尔滨150525
出 处:《中国药品标准》2017年第4期275-278,共4页Drug Standards of China
摘 要:目的:对开塞露(含甘油)含量测定方法进行改进。方法:改变样品的取样量,按国家药品标准WS1-XG-018-2011对不同厂家的开塞露(含甘油)进行含量测定。结果:样品的取样量在0.10~0.19 g之间,反应完全,滴定结果准确,重现性好。结论:改进方法后,能更准确的测定甘油的含量,建议修改原标准。Objective: To improve the method for the determination of enema in Glycerol Enema. Methods: Via changing the sampling volume, and combined with the dose-response relationship of sample and reagent volume, in accordance with the national drug standard WS1-XG-018-2011 test method for determination, several batches of Glycerol Enema from different manufacturers were determined. Results: When the sample volume is from 0. 10 g to 0. 19 g, the reaction will achieve complete response, the titration results are accurate and the reproducibility is good. Conclusion: It is more accurate to determine the content of glycerol after reducing the amount of sample. The original standard should be revised.
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